Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2016-12-11
2018-04-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic Control
NCT02517242
A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle
NCT00602914
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
NCT06609356
Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
NCT02443714
Glucose Measurement Using Microneedle Patches
NCT02682056
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Compare the metabolic evolution of patients with DKA using a flexible subcutaneous catheter for insulin administration vs. a metal needle.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
flexible catheter
The flexible Subcutaneous catheter for insulin administration
FLEXIBLE CATHETER
hourly rigid needle puncture
Hourly rigid needle puncture for Subcutaneous insulin administration
hourly rigid needle puncture
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FLEXIBLE CATHETER
hourly rigid needle puncture
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Glucose\> 200 mg / dl
* pH \< 7.3
* Bicarbonate \< 15mmol/l.
Exclusion Criteria
5 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital General de Niños Pedro de Elizalde
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura Beaudoin, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Niños Pedro de Elizalde
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Constitucion, Argentina
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hanas R, Adolfsson P, Elfvin-Akesson K, Hammaren L, Ilvered R, Jansson I, Johansson C, Kroon M, Lindgren J, Lindh A, Ludvigsson J, Sigstrom L, Wiik A, Aman J. Indwelling catheters used from the onset of diabetes decrease injection pain and pre-injection anxiety. J Pediatr. 2002 Mar;140(3):315-20. doi: 10.1067/mpd.2002.122470.
Beaudoin ML, Torrents M, Tittarelli MF, Hamui M, Ibarra M, Ferraro M, Ferreira JP. Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis: A Feasibility Controlled Clinical Trial. Hosp Pediatr. 2021 Apr;11(4):396-400. doi: 10.1542/hpeds.2020-0063. Epub 2021 Mar 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HGNPE-247-2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.